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Trial record 1 of 1 for:    NCT00333034
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Study Evaluating the Safety and Efficacy of Etanercept 50 mg Once Weekly in Subjects With Psoriasis

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ClinicalTrials.gov Identifier: NCT00333034
Recruitment Status : Completed
First Posted : June 2, 2006
Last Update Posted : December 6, 2007
Sponsor:
Collaborator:
Amgen
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Tracking Information
First Submitted Date  ICMJE May 23, 2006
First Posted Date  ICMJE June 2, 2006
Last Update Posted Date December 6, 2007
Study Start Date  ICMJE June 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: June 1, 2006)
The primary efficacy endpoint is the PASI 75 response at week 12. PASI 75 is defined as a 75% or greater improvement in PASI score from baseline.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00333034 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 1, 2006)
  • The secondary efficacy endpoints will include but not limited to: PASI 50, PASI 75 (at visit other than week 12, PASI 90, PASI score PGA of 0 or 1 (clear or minimal, Patient global assessment of psoriasis, DLQI,
  • EQ5D, FACIT-F.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study Evaluating the Safety and Efficacy of Etanercept 50 mg Once Weekly in Subjects With Psoriasis
Official Title  ICMJE A Multicenter, Parallel, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of Etanercept 50 mg Once Weekly in Subjects With Moderate to Severe Plaque Psoriasis
Brief Summary The primary objective is to assess the efficacy and safety of etanercept 50 mg administered once weekly in subjects with psoriasis over 12 weeks.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Psoriasis
Intervention  ICMJE Drug: Etanercept
Study Arms  ICMJE Not Provided
Publications * Griffiths CE, Christophers E, Szumski A, Jones H, Mallbris L. Impact of early vs. late disease onset on treatment response to etanercept in patients with psoriasis. Br J Dermatol. 2015 Nov;173(5):1271-3. doi: 10.1111/bjd.13865. Epub 2015 Aug 17.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: June 1, 2006)
120
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE Inclusion Criteria: -Adults greater than or equal to 18 years of age with clinically stable plaque psoriasis involving greater than or equal to 10% of the body surface and a minimum Psoriasis Area and Severity Index (PASI) score of 10 at screening. -Failure to respond to, or have a contraindication to, or intolerant to at least 1 of the following systemic or phototherapies at an adequate dose of sufficient duration: Methotrexate (MTX), Acitretin, Cyclosporine, Ultraviolet A (UVA), Ultraviolet B (UVB), Psoralen and Ultraviolet A (PUVA), Fumarate Exclusion Criteria: -Previous treatment with etanercept, antibody to TNF or other TNF inhibitors. -Active guttate, erythrodermic, or pustular psoriasis at the time of the screening or baseline.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Belgium,   France,   Germany,   Hungary,   Italy,   Netherlands,   Poland,   Romania,   Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00333034
Other Study ID Numbers  ICMJE 0881A6-318
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators  ICMJE Amgen
Investigators  ICMJE
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For Austria, medinfo@wyeth.com
Principal Investigator: Trial Manager For Belguim, trials-BEL@wyeth.com
Principal Investigator: Trial Manager For France, infomedfrance@wyeth.com
Principal Investigator: Trial Manager For Germany, medinfoDEU@wyeth.com
Principal Investigator: Trial Manager For Hungary, WPBUMED@wyeth.com
Principal Investigator: Trial Manager For Italy, descresg@wyeth.com
Principal Investigator: Trial Manager For Netherlands, trials-NL@wyeth.com
Principal Investigator: Trial Manager For Poland, WPWZMED@wyeth.com
Principal Investigator: Trial Manager For Romania, WVPIMED@wyeth.com
Principal Investigator: Trial Manager For Spain, infomed@wyeth.com
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP